U.S. Food and Drug Administration Updates for Health Professionals
As part of the FDA’s efforts to keep health professionals informed about FDA issues, below is included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY:
Expansion of Nationwide Voluntary Recall of Specific Lots of Sexual Enhancement Products Marketed as Dietary Supplements (April 12)
Atlas Operations, Inc. announced a voluntary nationwide recall of the company’s dietary supplements for sexual enhancement to include Stamin It, Erectzia, and Vigor 100. These products were sold as dietary supplements throughout the United States. Atlas Operations, Inc. is conducting a voluntary recall after being informed by FDA that lab analyses found that the products to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.
Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall (Apr 8)
Recall has been classified as Class I. Product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged.
Camolyn eye drops, Fisiolin nasal drops: Voluntary recall due to non-sterility (Apr 7)
Lack of sterile product has the potential to cause infections.
Heparin: Change in Reference Standard (Apr 7)
New studies reinforce FDA’s previous recommendation for healthcare professionals to exercise clinical judgment in determining the dose of heparin for a patient.
PRODUCT APPROVALS:
FDA Approves Pancreatic Enzyme Product, Pancreaze (Apr 12)
FDA approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). It is the third such product to receive FDA approval. Pancreatic enzyme products improve food digestion in patients whose bodies do not produce enough.
FDA Approves First Generic Versions of Two Drugs for the Treatment of Hypertension (Apr 6)
FDA approved the first generic versions of two drugs used for the treatment of hypertension. Losartan potassium tablets and losartan potassium and hydrochlorothiazide tablets (a combination drug) are the generic equivalents of Cozaar and Hyzaar tablets, respectively.
FDA Approves New Formulation for OxyContin (Apr 5)
FDA approved a new formulation of the controlled-release drug OxyContin that has been designed to help discourage misuse and abuse of the medication.
FDA Approves First Biodegradable Sealant Patch for Cardiovascular Surgery (Apr 5)
FDA approved TachoSil, the first absorbable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels, when standard surgical techniques are ineffective or impractical.
ANNOUNCEMENTS:
Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available (Apr 13)
FDA announced, in accordance with longstanding U.S. obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer, seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD) will be gradually removed from the U.S. marketplace. These inhalers contain ozone-depleting chlorofluorocarbons (CFCs), which are propellants that move medication out of the inhaler and into the lungs of patients. Alternative medications that do not contain CFCs are available.
FDA Patient Safety News Video Broadcasts (Apr 8)
April 2010 video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.
FDA MedWatch Mobile Text Messaging
The FDA recently launched a new MedWatch Safety Information mobile text message program. The content of the text messages will consist of alerts that provide timely new safety information on human drugs, medical devices, and related safety topics. The messages contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient. To subscribe to the pilot, text FDA to 87000. Subscribers can expect to receive approximately three to five text messages a week during the six-month pilot. Standard text messaging rates will apply.